{"doc_desc":{"title":"Registre des cancers p\u00e9diatriques du grand ouest","idno":"FRESH-PEF73258-fr","producers":[{"name":"Isabelle PELLIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73258-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73258"},{"agency":"FReSH","code":"FRESH-PEF73258"}]},"title":"Registre des cancers p\u00e9diatriques du grand ouest","alternate_title":"ReCaPGO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Isabelle;PELLIER","PILabo":"CHU Angers","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","extlink":[{"title":"ORCID","uri":"0000-0002-7988-4712","role":"pi id"},{"title":"IdRef","uri":"176539840","role":"pi id"},{"title":"SIREN","uri":"264900036","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"IsPellier@chu-angers.fr","isContact":"Oui"}],"oth_id":[{"name":"Consortium des 7 CHU et des 2 CLCC du R\u00e9seau GOCE (Grand Ouest Cancers de l'Enfant), organisation interr\u00e9gionale (OIR) reconnue par l'INCa depuis 2010.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":""}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]}]},"distribution_statement":{"contact":[{"name":"Isabelle;PELLIER","email":"IsPellier@chu-angers.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0250ngj72","role":"organisation id","title":"ROR"},{"uri":"264900036","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"grand ouest"},{"keyword":"Cancer"},{"keyword":"p\u00e9diatrie"},{"keyword":"registre sp\u00e9cialis\u00e9"},{"keyword":"tumeurs solides"},{"keyword":"h\u00e9mopathies malignes"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Tumeurs malignes de localisations primitives mal d\u00e9finies ou non pr\u00e9cis\u00e9es","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1594217552","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est de renforcer la structuration existante de recueil de donn\u00e9es afin d\u2019apporter expertise et soutien (m\u00e9thodologique, logistique, qualit\u00e9) aux \u00e9quipes de l\u2019interr\u00e9gion. Elle permet de (1) Disposer, sur le territoire interr\u00e9gional, des principales informations n\u00e9cessaires \u00e0 une prise en charge globale des malades depuis le diagnostic et sur la p\u00e9riode du long terme o\u00f9 sont susceptibles de se d\u00e9voiler les s\u00e9quelles de la prise en charge initiale (2) Soutenir l\u2019\u00e9mergence de projets de recherche","abstract":"","coll_dates":[{"start":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine','Bretagne','Centre-Val de Loire','Normandie','Pays de la Loire']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients de moins de 25 ans pris en charge par les \u00e9quipes d'oncologie p\u00e9diatrique dans les 7 CHU de l\u2019inter r\u00e9gion pour un cancer, une h\u00e9mopathie maligne, une histiocytose ou une aplasie m\u00e9dullaire.  Consentement parents +\\\/-enfant\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"559"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Chaque \u00e9tablissement du r\u00e9seau GOCE participant \u00e0 la base de donn\u00e9es ReCaPGO a sign\u00e9 un accord de consortium sp\u00e9cifiant les modalit\u00e9s d'utilisation par les \u00e9tablissements composant le r\u00e9seau GOCE des donn\u00e9es et des r\u00e9sultats li\u00e9s \u00e0 ReCaPGO ainsi que les autorisations d'exploitation et de cession des donn\u00e9es cliniques. Ce consortium a \u00e9t\u00e9 sign\u00e9 par l'ensemble des directions g\u00e9n\u00e9rales des \u00e9tablissements de GOCE (CHU Angers, CHU Brest, CHU Caen, CHU Nantes, CHU Poitiers, CHU Rennes, CHU Tours, Institut de canc\u00e9rologie de l'Ouest (ICO) Nantes, Centre Eug\u00e8ne Marquis Rennes) entre le 18 mars 2014 et le 04 juin 2014 pour une p\u00e9riode de 5 ans renouvelable. Afin de participer au registre ReCaPGO, chaque demandeur devra adresser sa candidature \u00e9crite et argument\u00e9e au coordinateur du conseil scientifique de GOCE qui la pr\u00e9sentera \u00e0 l\u2019ensemble des repr\u00e9sentants m\u00e9dicaux. L\u2019acceptation d\u2019un nouveau Centre au Registre devra recevoir l\u2019accord \u00e0 l\u2019unanimit\u00e9 des Centres participant d\u00e9j\u00e0 au Registre. Cela devra \u00eatre formalis\u00e9 par voie d\u2019avenant au pr\u00e9sent consortium, sign\u00e9 de l\u2019ensemble des Parties.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"03-11-2015","isContributorPI":"Non","contributorName":"Isabelle PELLIER","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE D'ANGERS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.girci-go.org\/OUTILS_INTERREGIONAUX\/documents\/PresentationSPRINGGOCE.pdf"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":[],"otherSponsorType":[]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Saisie des donn\u00e9es par les Techniciens d\u2019Etude Clinique (TEC)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Grand Ouest"},"dataTypes":{"clinicalDataDetails":"Identit\u00e9 , Tumeur : Diagnostic, Passage en RCP, Parcours de soins, Bilan traitements, S\u00e9quelles de fin de traitement. Suivi \u00e0 long terme. Echantillons disponibles (lien avec la tumoroth\u00e9que virtuelle grand ouest, canc\u00e9ropole )","biologicalDataDetails":"","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}